Glenmark Pharmaceuticals Secures License for Cancer Treatment Drug Envafolimab in Key Global Regions

25 Jan 2024 , 03:25 PM

Glenmark Pharmaceuticals Ltd’s arm, Glenmark Specialty S A (GSSA), has signed a license agreement with Jiangsu Alphamab Biopharmaceuticals Co and 3D Medicines (Beijing) Co Ltd for KN035 (Envafolimab) used in cancer treatment.

The license agreement grants Glenmark rights for KN035 (Envafolimab) in India, Asia Pacific, the Middle East, Africa, Russia, CIS, and Latin America.

Glenmark will take on the responsibility for further development, registration, and commercialization of Envafolimab in these regions.

Jiangsu Alphamab, on behalf of the licensors, will receive a low double-digit million US dollar amount up to launch, additional triple-digit million US dollar milestone payments based on sales performance, and a royalty fee of single to double digits depending on net sales.

Jiangsu Alphamab will handle the manufacturing of KN035 and be the exclusive supplier of the product.

This deal is a significant milestone for Glenmark, providing access to the first recombinant humanized single domain antibody against PD-L1 in a Sub-Q formulation globally, according to Glenmark Pharmaceuticals Chairman & Managing Director Glenn Saldanha.

Envafolimab, approved as ENWEIDA in China in November 2021, is indicated for treating adult patients with certain types of advanced solid tumors. It is included in the ‘List of Breakthrough Therapies’ by the Chinese National Medical Products Administration.

Currently, Envafolimab is being developed in the USA by Tracon Pharma in a pivotal trial for soft tissue sarcoma (STS) subtypes.

The drug holds two orphan drug designations from the USFDA for advanced biliary tract cancer and STS, along with a fast-track designation for STS. Additional indications like biliary tract cancer and non-small cell lung cancer are in development.

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